Address
Form of workResponsibilities:
Requirements:
- Develop and implement audit plans for suppliers.
- Conduct audits of supplier facilities, processes, and documentation
- Interview personnel, observe operations, and review records.
- Identify and assess any deficiencies in the supplier's quality management system.
- Work with suppliers to develop corrective action plans.
- Follow up to ensure that corrective actions have been implemented effectively.
- Prepare audit reports that document the findings and recommendations.
- Stay up-to-date on regulatory requirements for the medical device industry
- Maintain relationships with suppliers and work collaboratively to improve their quality management systems.
Requirements:
- Bachelor's degree in a related field, such as engineering, science, or business
- 3+ years of experience in quality assurance, preferably in the medical device industry
- Experience in conducting audits of suppliers.
- Strong understanding of medical device design and development regulations, medical device manufacturing best practices, quality management system standards, and FDA regulatory requirements
- Excellent written and verbal communication skills
- Ability to work independently and as part of a team.
- Certified Medical Device Auditor (CMDA) certification
- Experience with ISO 13485 and other quality management system standards
- Experience with FDA regulatory inspections
